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A hypercoagulable disorder is a condition that increases the risk of inappropriate or excessive thrombos (blood clot) formation in a patient. Hypercoagulation-related disorders are divided in two major categories. The first includes the inherited hypercoagulable states, such as Factor V Leiden; prothrombin gene mutation; elevated levels of fibrinogen; deficiencies of anticoagulant proteins, such as antithrombin, protein C and protein S; sticky platelets and abnormal fibrinolytic system, including hypoplasminogenia, dyspasminogenia, and elevation in levels of PAI-1. The second category of hypercoagulation-related disorders includes the acquired hypercoagulable diseases. These diseases result from reversible or irreversible causes, including: cancer and cancer related disorders, such as adenocarcinomas, metastatic cancer, cancer treatment, hematological malignancies (i.e., myeloproliferative disorders, paroxysmal nocturnal hemoglobinuria and hyperviscosity syndromes); autoimmune disorders, such as antiphospholipid antibody syndrome (APS), systemic lupus erythematosus (SLE), inflammatory bowel diseases, heparin-induced thrombocytopenia and vasculitis; acute infection and sepsis; recent trauma or surgery; prolonged bedrest or inactivity; long air travel; atherosclerosis; hypertension; nephrotic syndrome; pregnancy; extracorporeal circulation; artificial vascular devices; obesity; and previous deep vein thrombosis or pulmonary embolism.
Hypercoagulable states (also called thrombophilias, thrombotic disorders and prothrombotic disorders) with consequent thrombotic manifestations, constitute a major life threatening clinical problem. Although there are functional tests to support the differential diagnosis of some inherited hypercoagulable states, currently no specific functional test exists to support the diagnosis of acquired thrombotic disorder. In recent years, advances in understanding of the natural anticoagulant and fibrinolytic system have been translated into preliminary diagnostic tools known as “thrombotic” or “thrombophilic” tests. However, the algorithmic diagnostic procedure generally used today in efforts to solve clinical problems related to hypercoagulation does not include “thrombotic” tests, because there is no specific thrombophilic laboratory profile of hypercoagulable and thrombotic disorders. Furthermore, the high cost and laborious technology involved have further hindered the practical clinical application of such assays.
Thus, there is a need in the art for an assay that is useful in the differential diagnosis of acquired thrombophilia disorder.